SIST EN 868-5:2019
(Main)Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und Prüfverfahren
Dieses Dokument legt Prüfverfahren und Werte für siegelfähige Klarsichtbeutel und schläuche aus porösem Material fest, die entweder EN 868 Teil 2, Teil 3, Teil 6, Teil 7, Teil 9 oder Teil 10 entsprechen und aus Kunst¬stoff Verbundfolie nach Abschnitt 4 hergestellt werden. Diese siegelfähigen Klarsichtbeutel und schläuche werden als Sterilbarrieresysteme und/oder Verpackungssysteme verwendet, die dafür bestimmt sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607 1 und EN ISO 11607 2 festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, die spezifisch für die in diesem Dokument betrachteten Produkte sind.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essai
Le présent document spécifie des méthodes d’essai et des valeurs relatives aux sachets et gaines scellables fabriqués à partir de matériaux poreux conformes à l’EN 868, Partie 2, 3, 6, 7, 9 ou 10, et en film plastique, conformément à l’Article 4. Ces sachets et gaines scellables servent de systèmes de barrière stérile et/ou de systèmes d’emballage destinés à maintenir l’état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu’au point d’utilisation.
Outre les exigences générales telles que spécifiées dans l’EN ISO 11607 1 et l’EN ISO 11607 2, la présente partie de l’EN 868 spécifie les matériaux, les méthodes d’essai et les valeurs spécifiques aux produits traités dans le présent document.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
Embalaža za končno sterilizirane medicinske pripomočke - 5. del: Vrečke in zvitki papirja z možnostjo tesnjenja (samolepilni) iz poroznega materiala in s plastičnimi folijami - Zahteve in preskusne metode
Ta del standarda EN 868 podaja preskusne metode in vrednosti za vrečke in zvitke iz poroznega materiala z možnostjo tesnjenja, izdelane v skladu s standardom EN 868, deli 2, 3, 6, 7, 9 ali 10, in plastične folije v skladu s točko 4, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
OPOMBA 1: Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik. Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki veljajo za proizvode, zajete v tem delu standarda EN 868, vendar ne dodaja ali spreminja splošnih zahtev, podanih v standardu EN ISO 11607-1.
Posebne zahteve iz točk od 4.2 do 4.5 je mogoče uporabiti za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.
OPOMBA 2: Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, kazalniki filtrov, embalažni listi, podloge, kompleti organizatorjev za inštrumente, obloge za pladnje ali dodatni ovoj okoli medicinskega pripomočka), se lahko uporabljajo druge zahteve, vključno z ugotavljanjem sprejemljivosti teh materialov med preverjanjem.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und PrüfverfahrenEmballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essaiPackaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je istoveten z:EN 868-5:2018SIST EN 868-5:2019en,fr,de01-marec-2019SIST EN 868-5:2019SLOVENSKI
STANDARDSIST EN 868-5:20091DGRPHãþD
SIST EN 868-5:2019
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 868-5
December
t r s z ICS
s sä r z rä u r Supersedes EN
z x zæ wã t r r {English Version
Packaging for terminally sterilized medical devices æ Part
wã Sealable pouches and reels of porous materials and plastic film construction æ Requirements and test methodsEmballages des dispositifs médicaux stérilisés au stade terminal æ Partie
wã Sachets et gaines scellables constitués d 5une face matière poreuse et d 5une face film plastique æ Exigences et méthodes d 5essai
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte æ Teil
wã Siegelfähige Klarsichtbeutel und æschläuche aus porösen Materialien und KunststoffæVerbundfolie æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on
t r August
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
9
t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
z x zæ wã t r s z ESIST EN 868-5:2019
EN 868-5:2018 (E) 2 Contents Page European foreword . 3 Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 6 4 Requirements . 7 4.1 General . 7 4.2 Materials . 7 4.2.1 Porous material . 7 4.2.2 Plastic film . 7 4.3 Construction and design . 8 4.4 Process indicator . 8 4.5 Performance requirements and test methods . 8 4.6 Marking . 9 4.6.1 Pouches and reels . 9 4.6.2 Transport and/or storage packaging . 10 5 Information to be supplied by the manufacturer . 10 Annex A (informative)
Details of significant technical changes between this document and the previous edition . 11 Annex B (normative)
Method for the determination of resistance to the intended sterilization process . 12 Annex C (normative)
Method for the determination of pinholes in plastic laminate . 13 Annex D (normative)
Method for the determination of the strength of the seal for pouches and reel material . 15 Annex E (normative)
Method for the determination of peel characteristics of paper/plastic laminate products . 18 Annex F (normative)
Method for the determination of fibre orientation . 20 Bibliography . 21
SIST EN 868-5:2019
EN 868-5:2018 (E) 3 European foreword This document (EN 868-5:2018) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2019, and conflicting national standards shall be withdrawn at the latest by June 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-5:2009. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: — Part 2: Sterilization wrap — Requirements and test methods; — Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods; — Part 4: Paper bags — Requirements and test methods; — Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods; — Part 6: Paper for low temperature sterilization processes — Requirements and test methods; — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods; — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods; — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods; — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods. In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” has prepared the EN ISO 11607 series “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1) and validation requirements for forming, sealing and assembly processes (Part 2). According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, SIST EN 868-5:2019
EN 868-5:2018 (E) 4 Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 868-5:2019
EN 868-5:2018 (E) 5 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices”. Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards. It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series. SIST EN 868-5:2019
EN 868-5:2018 (E) 6 1 Scope This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document. The materials specified in this part of EN 868 are intended for single use only. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 868-2:2017, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods EN 868-3:2017, Packaging for terminally sterilized medical devices — Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods EN 868-6:2017, Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization processes — Requirements and test methods EN 868-7:2017, Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods EN 868-9:2018, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods EN 868-10:2018, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1) EN ISO 11607-1:2017, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ASTM D882:2012, Test Methods for Tensile Properties of the Thin Plastic Sheeting ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2017 apply. SIST EN 868-5:2019
EN 868-5:2018 (E) 7 ISO and IEC maintain terminological databases for use in standardization at the following addresses: — IEC Electropedia: available at http://www.electropedia.org/ — ISO Online browsing platform: available at http://www.iso.org/obp 4 Requirements 4.1 General For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1 shall apply. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 868-5 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-5 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply. 4.2 Materials 4.2.1 Porous material The porous material shall comply with the requirements of Clause 4 of either EN 868-2:2017, EN 868-3:2017, EN 868-6:2017, EN 868-7:2017, EN 868-9:2018 or EN 868-10:2018. If the intended method of sterilization is irradiation only, the requirements for wet strength properties and permeability to air for porous materials are not applicable. 4.2.2 Plastic film 4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance with Annex B the plastics interply bond shall not separate nor become cloudy. 4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C. 4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4.5. NOTE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect. 4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified. SIST EN 868-5:2019
EN 868-5:2018 (E) 8 4.2.2.5 The breaking factor of the plastics film, machine direction and cross direction, shall be not less than 20 N per 15 mm width when tested in accordance with ASTM D882:2012 (Method A). 4.3 Construction and design 4.3.1 Reel material shall be constructed from one web of porous material and one web of plastic film, sealed together along parallel sides. Pouches shall be constructed from one web of porous material and one web of plastic film by sealing three sides and may include an area to effect closure of the pouch. 4.3.2 The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the widths of the ribs shall be not less than 6 mm. 4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable the two webs to be separated and peeled apart. NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided that this does not impair peelability. 4.3.4 One of the materials of a pouch shall b
...
SLOVENSKI STANDARD
oSIST prEN 868-5:2017
01-oktober-2017
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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels
of porous materials and plastic film construction - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5:
Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-
Verbundfolie - Anforderungen und Prüfverfahren
Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 5 : Sachets et gaines thermoscellables constitués d'une face matière
poreuse et d'une face film plastique - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-5
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-5:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 868-5:2017
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oSIST prEN 868-5:2017
DRAFT
EUROPEAN STANDARD
prEN 868-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2017
ICS 11.080.30 Will supersede EN 868-5:2009
English Version
Packaging for terminally sterilized medical devices - Part
5: Sealable pouches and reels of porous materials and
plastic film construction - Requirements and test methods
Matériaux et systèmes d'emballage pour les dispositifs Verpackungen für in der Endverpackung zu
médicaux stérilisés au stade terminal - Partie 5 : sterilisierende Medizinprodukte - Teil 5: Siegelfähige
Sachets et gaines thermoscellables constitués d'une Klarsichtbeutel und -schläuche aus porösen
face matière poreuse et d'une face film plastique - Materialien und Kunststoff-Verbundfolie -
Exigences et méthodes d'essai Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-5:2017 E
worldwide for CEN national Members.
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oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements . 7
4.1 General . 7
4.2 Materials . 7
4.3 Construction and design . 8
4.4 Process indicator . 8
4.5 Performance requirements and test methods . 8
4.6 Marking . 9
5 Information to be supplied by the manufacturer . 10
Annex A (informative) Details of significant technical changes between this European
Standard and the previous edition . 11
Annex B (normative) Method for the determination of resistance to the intended
sterilization process . 12
B.1 Preparation of test specimens . 12
B.2 Procedure. 12
B.3 Test report . 12
Annex C (normative) Method for the determination of pinholes in plastic laminate . 13
C.1 Apparatus and reagents . 13
C.2 Preparation of test pieces . 13
C.3 Procedure. 13
C.4 Test report . 14
Annex D (normative) Method for the determination of the strength of the seal joint for
pouches and reel material . 15
D.1 Principle of the method . 15
D.2 Test method . 15
D.3 Preparation of test specimen - Instructions for sampling . 15
D.4 Procedure. 15
D.5 Test report . 16
Annex E (normative) Method for the determination of peel characteristics of paper/plastic
laminate products . 17
2
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prEN 868-5:2017 (E)
E.1 Apparatus . 17
E.2 Procedure . 17
E.3 Test report . 17
Annex F (normative) Method for the determination of fibre orientation . 18
F.1 Apparatus . 18
F.2 Procedure . 18
F.3 Test report . 18
Bibliography . 19
3
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oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
European foreword
This document (prEN 868-5:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 868-5:2009.
Annex A provides details of significant technical changes between this European Standard and the
previous edition.
EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical
devices:
— Part 2: Sterilization wrap — Requirements and test methods;
— Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture
of pouches and reels (specified in EN 868-5) — Requirements and test methods;
— Part 4: Paper bags — Requirements and test methods;
— Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements
and test methods;
— Part 6: Paper for low temperature sterilization processes — Requirements and test methods;
— Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test
methods;
— Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements
and test methods;
— Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods;
— Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods.
In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” has prepared the
EN ISO 11607 series “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series
specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1)
and validation requirements for forming, sealing and assembly processes (Part 2).
4
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oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
Introduction
The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally
sterilized medical devices”. Part 1 of this series specifies general requirements and test methods for
materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are
intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this
series specifies validation requirements for forming, sealing and assembly processes.
General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1.
The EN 868 series can be used to demonstrate compliance with one or more of the requirements
specified in EN ISO 11607-1.
CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse
environmental impacts by standards. It was agreed that this subject should be given priority during the
next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series.
5
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oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
1 Scope
This European Standard specifies test methods and values for sealable pouches and reels manufactured
from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying
with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain
sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of
EN 868 specifies materials, test methods and values that are specific to the products covered by this
European Standard.
The materials specified in this part of EN 868 are intended for single use only.
Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of
the work item in order to align the scope with the recently published new editions of EN 868-2, −3, 4- −6
and −7. Please consider that a positive ballot on prEN 858-5 during enquiry includes the approval of the
revised scope.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 868-2:2017, Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap -
Requirements and test methods
EN 868-3:2017, Packaging for terminally sterilized medical devices - Part 3: Paper for use in the
manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified
in EN 868-5) - Requirements and test methods
EN 868-6:2017, Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature
sterilization processes - Requirements and test methods
EN 868-7:2017, Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for
low temperature sterilization processes - Requirements and test methods
prEN 868-9:2017, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven
materials of polyolefines — Requirements and test methods
prEN 868-10:2017, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated
nonwoven materials of polyolefines — Requirements and test methods
EN ISO 11140-1, Sterilization of health care products - Chemical indicators - Part 1: General requirements
(ISO 11140-1)
EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ASTM D882:2012, Test Methods for Tensile Properties of the Thin Plastic Sheeting
ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
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oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009 apply.
4 Requirements
4.1 General
For any material, preformed sterile barrier system or sterile barrier system, the requirements of
EN ISO 11607-1 shall apply.
This part of EN 868 only introduces performance requirements and test methods that are specific to the
products covered by this part of EN 868 but does not add or modify the general requirements specified
in EN ISO 11607-1.
As such, the particular requirements in 4.5 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
NOTE 1 Compliance to EN 868–5 does not automatically mean compliance to EN ISO 11607.
A confirmation of compliance to EN 868-5 shall contain a statement whether EN ISO 11607-1 is
covered.
NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization,
drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray
liners or an additional envelope around the medical device) then other requirements, including the determination
of the acceptability of these materials during validation activities, can apply.
4.2 Materials
4.2.1 Porous material
The porous material shall comply with the requirements of Clause 4 of either EN 868-2:2017,
EN 868-3:2017, EN 868-6:2017, EN 868-7:2017, prEN 868-9:2017 or prEN 868-10:2017.
If the intended method of sterilization is irradiation only, the requirements for wet strength properties
and permeability to air for porous materials are not applicable.
4.2.2 Plastic film
4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended
sterilization process in accordance with Annex B the plastics interply bond shall not separate nor
become cloudy.
4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C.
4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or
good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that
would a
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